drugset / Trial / NCT07284654
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2027-01
- Completion
- 2027-01
Outcome
Met primary endpoint
release “In the OPUS-1 trial, VAX-31 met all prespecified co-primary immunogenicity endpoints in adults 50 and older” vaxcyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PCV20 | Vaccine | 0.5 ml | Intramuscular |
| Comparator | PCV21 | Vaccine | 0.5 ml | Intramuscular |
| Subject | VAX-31 | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.